MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ANTHEM RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/29/2018

Event Type  Death  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the patient expired.There is no known allegation from a health professional that suggests the death was related to the device.It was reported that the cause of death is unknown.Related manufacturer reference number: 2017865-2019-15894, 2017865-2019-15895, 2017865-2019-15896.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: ANTHEM RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 9272545
• MDR Text Key: 164857268
• Report Number: 2017865-2019-15893
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734503785
• UDI-Public: 05414734503785
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: PM3210
• Device Catalogue Number: PM3210
• Device Lot Number: 3626566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 02/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: QUICKFLEX; TENDRIL SDX; TENDRIL STS
• Patient Outcome(s): Death
• Patient Age: 87 YR